Metrogel Vaginal

"Investigators from the Women's Health Initiative (WHI) Hormone Trials are reaffirming conclusions that hormone therapy is not recommended for the prevention of chronic disease, but may remain a reasonable option for the short-term management "...

For Patients

Metrogel vaginal (metronidazole) is an antibiotic used to treat bacterial vaginosis. Side effects of Metrogel vaginal may include burning or stinging when the medicine is applied, numbness, pelvic pain or cramping, loss of appetite, constipation, upset stomach, vomiting, dizziness, sleep problems (insomnia), runny nose, urinating more than usual, acne, increased sweating, breast discharge or enlargement, or seizure.

The recommended dose is one applicator full of Metrogel- Vaginal (approximately 5 grams containing approximately 37.5 mg of metronidazole) intravaginally once or twice a day for 5 days. There has been no experience to date with the use of METROGEL-VAGINAL (metronidazole) in pregnant patients. Metronidazole crosses the placental barrier and enters the fetal circulation rapidly. There are, however, no well-controlled studies of this drug in pregnant women. Because metronidazole is a carcinogen in rodents, this drug should be used during pregnancy only if clearly needed. Metronidazole is secreted in human milk in concentrations similar to those found in plasma following oral administration of metronidazole.

Our Metrogel vaginal Side Effects Drug Center provides a comprehensive view of available drug information on the potential side effects when taking this medication.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

What is Patient Information in Detail?

Easy-to-read and understand detailed drug information and pill images for the patient or caregiver from Cerner Multum.

SIDE EFFECTS: Dizziness, headache, nausea, diarrhea, unusual taste in the mouth, stomach cramps, or vaginal itching/burning/discharge may occur. If any of these effects persist or worsen, notify your doctor or pharmacist promptly.

Remember that your doctor has prescribed this medication because he or she has judged that the benefit to you is greater than the risk of side effects. Many people using this medication do not have serious side effects.

Tell your doctor immediately if any of these unlikely but serious side effects occur: fainting, painful urination.

Tell your doctor immediately if any of these rare but very serious side effects occur: tingling or numbness of the hands and feet, seizures, signs of another infection (e.g., fever, persistent sore throat), mental/mood changes (e.g., depression).

Use of this medication for prolonged or repeated periods may result in a new vaginal yeast infection (vaginal fungal infection). Contact your doctor if you notice a change in vaginal discharge or other new symptoms.

A very serious allergic reaction to this drug is unlikely, but seek immediate medical attention if it occurs. Symptoms of a serious allergic reaction may include: rash, itching/swelling (especially of the face/tongue/throat), severe dizziness, trouble breathing.

This is not a complete list of possible side effects. If you notice other effects not listed above, contact your doctor or pharmacist.

In the US -

Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

In Canada - Call your doctor for medical advice about side effects. You may report side effects to Health Canada at 1-866-234-2345.

SIDE EFFECTS

Clinical Trials

There were no deaths or serious adverse events related to
drug therapy in clinical trials involving 800 non-pregnant women who received METROGEL-VAGINAL (metronidazole) .

In a randomized, single-blindclinical trial of 505
non-pregnant women who received METROGEL-VAGINAL (metronidazole) once or twice a day, 2 patients (one from each regimen) discontinued therapy
early due to drug-related adverse events. One patient discontinued drug because of moderate abdominal cramping and loose stools,
while the other patient discontinued drug because of mild vaginal burning. These symptoms resolved after discontinuation of drug.

Medical events judged to be related, probably related, or
possibly related to administration of METROGEL-VAGINAL (metronidazole) once or twice a day were reported for 195/505 (39%) patients. The
incidence of individual adverse reactions were not significantly different
between the two regimens. Unless percentages are otherwise
stipulated, the incidence of individual adverse reactions listed below was less
than 1%:

Laboratory

Other Metronidazole Formulations

Other effects that have been reported in association with
the use of topical (dermal) formulations of metronidazole include skin irritation, transient skin erythema, and mild skin dryness
and burning. None of these adverse events exceeded an incidence of 2% of patients.

METROGEL-VAGINAL (metronidazole) affords minimal peak serum levels and
systemic exposure (AUC) of metronidazole compared to 500 mg oral metronidazole dosing. Although these lower levels of
exposure are less likely to produce the common reactions seen with oral metronidazole, the possibility of these and other reactions
cannot be excluded presently.

The following adverse reactions and altered laboratory tests
have been reported with the oral or parenteraluse of metronidazole:

Cardiovascular: Flattening of the T-wave may be seen in electrocardiographic
tracings.